Search Results for: "amgen v apotex"

Federal Circuit Oral Arguments in NYC Today

This week, six Federal Circuit panels will hear oral argument on at various venues in New York City.  Two of today’s oral arguments are in biosimilar cases that we have been closely following on this blog. First, at 10:00 AM, a panel will hear oral argument at the U.S. Court…

Read More

BPCIA Litigation Roundup (Spring 2017)

Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017).

Read More

Briefing Complete in Appeal in Amgen v. Apotex

The parties in Amgen v. Apotex have completed briefing in Amgen’s appeal to the Federal Circuit from the district court’s judgment of noninfringment.  As we have previously reported, in September 2016 the District Court for the Southern District of Florida ruled that Apotex’s proposed filgrastim and pegfilgrastim products will not…

Read More

Year in Review: The Top-Five Legal Developments of 2016

Here are our picks for the top-five most significant legal developments in the world of biosimilars in 2016: 5) Congress passed and President Obama signed the 21st Century Cures Act.  Among other things, the Act modifies the standards and review processes for FDA evaluation of applications to market new drugs,…

Read More

Breaking News: Supreme Court Denies Cert. in Apotex v. Amgen

Today, the Supreme Court denied certiorari in Apotex v. Amgen, a closely-watched case involving the interpretation of key provisions of the BPCIA.  Our most recent blog coverage can be found here. Even though the Court has declined to hear Apotex v. Amgen, the Supreme Court has before it another vehicle for addressing the hotly-contested…

Read More